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NCT06433219CompletedPhase 2

Tuvusertib Combined With Niraparib or Lartesertib in Participants With Epithelial Ovarian Cancer (DDRiver EOC 302)

An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to measure the effect and safety of treatment with tuvusertib combined with either niraparib or lartesertib in participants with epithelial ovarian cancer and to assess any differences between tuvusertib monotherapy and combination therapy. The participants will previously have progressed while treated with a poly ADP ribose polymerase (PARP) inhibitor. The primary objectives of this study are to assess the effect of the treatment in terms of overall response, i.e. whether the tumor disappears, shrinks, remains unchanged, or gets worse and safety in terms of adverse events.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
63 (actual)
First submitted
22 May 2024
Start date
30 Oct 2024
Primary completion date
11 Aug 2026
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT06433219
EU CT number
2024-511202-23-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 63
  • From 30 Oct 2024 to the primary completion date, 11 Aug 2026
  • 85 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known brain metastases, unless clinically stable, that is without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention, no evidence of new brain metastases, and on a stable or decreasing dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at least 14 days prior to study intervention administration.
  • Organ transplantation, including allogenic stem cell transplant.

Other illness

  • Primary platinum-refractory disease defined as disease progression during primary platinum-based chemotherapy or platinum-resistant disease defined as disease progression within 6 months of the platinum administration in either the first or second-line setting.
  • History of additional malignancy within 3 years before the date of enrollment.
  • Active and/or uncontrolled infection.
  • History of known hypersensitivity to the active substances or to any excipients (e.g. polysorbate 80) of the study interventions.
  • Patients with history of drug-induced severe cutaneous adverse reaction (SCAR; including but not limited to Stevens-Johnson syndrome/toxic epidermal necrolysis \[SJS/TEN\], or drug reaction with eosinophilia and systemic symptoms \[DRESS\]), or dose-limiting immune-mediated reactions related to skin.

Other

  • Other Protocol defined exclusion criteria could apply.

Who the study is looking for

  • Histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is recurrent.
  • Participants whose tumor carries germline or somatic deleterious or suspected deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these mutations and/or the homologous recombination deficiency (HRD) status will be determined according to routinely used local standard of care tests. Results must be available before screening.
  • Radiologically confirmed/documented disease progression while on Poly (ADP-ribose) polymerase (PARP) inhibitors therapy in either first or second-line maintenance setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab). Note: Documentation of disease progression must be within 28 days of last PARPi dose taken. Surgical salvage intervention and/or focal ablative therapies are allowed, (further disease progression after these interventions must be documented), AND Clinically benefited from PARPi maintenance prior to documented progression, as defined by at least 6 months of treatment duration with no progressive disease observed, AND either, Progression on first-line maintenance PARPi: Participants are allowed maximum 1 additional line of platinum-based chemotherapy before study entry. (note: treatment-free interval on platinum rechallenge must be \>6 months, with documented disease progression prior to study entry).
    • OR Progression on second-line maintenance PARPi: Participants are not allowed any additional systemic anticancer treatments before study entry (that is PARPi is the last treatment before study entry)
  • Intolerant to standard of care treatment options or refused standard of care treatment or the participant's treating physician considers that the lack of standard of care treatment is not detrimental for the participant.
  • Measurable disease per RECIST v1.1, as assessed by Investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life expectancy of at least 6 months.
  • Other Protocol defined inclusion criteria could apply.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chris O'Brien Lifehouse
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
St George Private Hospital
Coordinator of this site? Confirm its status
KogarahAustraliaUnknown status
Liverpool Hospital - PARENT
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
UZ Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumCompleted
Centre Hospitalier Universitaire de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumCompleted
Cliniques Universitaires Saint-Luc
Coordinator of this site? Confirm its status
Sint-Lambrechts-WoluweBelgiumCompleted
Istituto Oncologico della Svizzera Italiana (IOSI)- Ente Ospedaliero Cantonale (EOC) - Ospedale S.Giovann
Coordinator of this site? Confirm its status
BellinzonaSwitzerlandUnknown status
Kantonsspital Frauenfeld - 150509250
Coordinator of this site? Confirm its status
FrauenfeldSwitzerlandUnknown status
Kantonsspital Baselland - standort Liestal - Klinik fuer Onkologie
Coordinator of this site? Confirm its status
LiestalSwitzerlandUnknown status
Kantonsspital St. Gallen - Klinik fuer Med. Onkologie/Haematologie
Coordinator of this site? Confirm its status
Sankt GallenSwitzerlandUnknown status
Universitaetsspital Zuerich - Klinik fuer Gynaekologie
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Universitaetsklinikum Bonn AöR
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BonnGermanyCompleted
Technische Universitaet Dresden
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DresdenGermanyCompleted
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyCompleted
Universitaet Leipzig
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LeipzigGermanyCompleted
Universitaet Muenster
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MuensterGermanyCompleted
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyCompleted
Aalborg University Hospital
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AalborgDenmarkCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Region Sjaelland
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RoskildeDenmarkCompleted
Hospital Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitari de Girona Doctor Josep Trueta
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GironaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Clinica Universidad de Navarra
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Institut de Cancerologie de L'Ouest
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AngersFranceCompleted
Centre Francois Baclesse
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Caen Cedex 5FranceCompleted
Clinique Victor Hugo
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Le MansFranceCompleted
Centre Oscar Lambret
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LilleFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Groupe Hospitalier Diaconesses Croix Saint-Simon
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ParisFranceCompleted
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
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Paris Cedex 14FranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 15FranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Groupe Hospitalier Saint Vincent
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StrasbourgFranceCompleted
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceCompleted
Institut Gustave Roussy
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VillejuifFranceCompleted
Addenbrooke's Hospital - Dept of Oncology
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre - Dept of Medical Oncology
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GlasgowUnited KingdomUnknown status
Royal Surrey County Hospital - Dept of Oncology
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GuildfordUnited KingdomUnknown status
St James's University Hospital - Dept of Oncology
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LeedsUnited KingdomUnknown status
Royal Marsden Hospital-London - Dept of Haematology/Oncology Research
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LondonUnited KingdomUnknown status
Guy's Hospital - Dept of Medical Oncology
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LondonUnited KingdomUnknown status
University College London Hospitals - NIHR/Wellcome Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie Hospital - Dept of Oncology
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ManchesterUnited KingdomUnknown status
Mount Vernon Hospital - Dept of Oncology
Coordinator of this site? Confirm its status
NorthwoodUnited KingdomUnknown status
Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)
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SuttonUnited KingdomUnknown status
Rambam Medical Center
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HaifaIsraelUnknown status
The Lady Davis Carmel Medical Center
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HaifaIsraelUnknown status
Hadassah University Hospital - Ein Kerem
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JerusalemIsraelUnknown status
Shaare Zedek
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JerusalemIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Azienda Ospedaliera per l Emergenza Cannizzaro
Coordinator of this site? Confirm its status
CataniaItalyCompleted
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Humanitas Mirasole S.p.A.
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MilanItalyCompleted
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
Istituto Oncologico Veneto
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PadovaItalyCompleted
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
Catharina Ziekenhuis Stichting
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EindhovenNetherlandsCompleted
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandCompleted
Jagiellonskie Centrum Innowacji Sp. z o.o.
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CracowPolandCompleted
Szpitale Pomorskie Sp z o o
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GdyniaPolandCompleted
Instytut MSF Sp. z o.o.
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LodzPolandCompleted
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandCompleted
Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.
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OtwockPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
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TorunPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center at Silver Cross - Carolyn J. Czerkies Pavilion
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ChicagoUnited StatesUnknown status
Centricity Research Cancer Center - DBA CRRI John B. Amos Cancer Center Research
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ColumbusUnited StatesUnknown status
Virginia Cancer Specialists PC
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FairfaxUnited StatesUnknown status
NEXT Oncology- Virginia
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FairfaxUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai PRIME - Mount Sinai - PRIME
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New YorkUnited StatesUnknown status
University of California San Francisco - UCSF Medical Center
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.